Molecular Phenotyping of Migraine Patients According to Sex and Age Through CGRP Quantification

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-75
SponsorHospital Universitari Vall d'Hebron Research Institute

About this trial

Patients will be asked to visit the study center 2 times, the first time for clinical assessment and a second time for sample collection. Healthy controls will only be asked to visit the study center for sample collection. A sample of blood and saliva will be collected in order to measure CGRP levels and DNA and hormone testing.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Migraine patients according to ICHD-3 criteria

Healthy controls paired to patient age and sex, without headache and without first degree family history of headache.

Disqualifiers

Presence of any major medical or neurological illness.

Presence of any salivary gland malfunction.

Abuse or dependence to tobacco, alcohol or any drug in the previous 12 months before the enrollment.

Active migraine preventive treatment.

Trial population

Males and females otherwise healthy with episodic and chronic migraine in different age groups will be included in the study. Controls matching age and sex will be selected for the control groups.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Saliva test

    Diagnostic test

    Sampling of CGRP in saliva and DNA blood test and sex hormones blood test.

Treatment groups

440 Participants
are divided into 2 treatment groups
Group A: Migraine Patients1 intervention
Group B: Control group1 intervention

Trial outcomes

Primary outcomes

1

CGRP level

Measure of CGRP in saliva

Time frame
Through study completion, an average of 1 year
2

Hormone levels

Blood test to quantify female hormones (FSH, LH, estradiol, progesterone, prolactin) and male hormones (testosterone) in all participants except for prepubertal children.

Time frame
Through study completion, an average of 1 year
3

DNA test

DNA testing for CGRP or its receptor related genes (CALCA, CALCB, CALCRL and RAMP1)

Time frame
Through study completion, an average of 1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

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